OPTIMIZATION OF MYCOPHENOLIC ACID TREATMENT IN RENAL TRANSPLANT RECIPIENTS
Phase 4
Completed
- Conditions
- Health Condition 1: null- Post renal transplant recipients after at least 3 weeks of renal transplantation
- Registration Number
- CTRI/2008/091/000250
- Lead Sponsor
- DEPARTMENT OF PHARMACOLOGY AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Patients coming for follow up at Nephrology Outpatient Department at AIIMS, New Delhi, who were having renal transplantation for at least 3 weeks before, age between 20-60 years, belonging to either sex, receiving MMF or EC-MPS for a minimum period of 7 days with tacrolimus and steroid in the treatment regimen were candidates for inclusion in the study.
Exclusion Criteria
Patients not agreed for written informed consent, using any other immunosuppressant, insufficient address for follow-up, or unwillingness to return for follow-up were not admitted to the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomeTimepoint: The primary endpoint was to correlate mycophenolic acid area under the concentration-time curve with acute graft dysfunction episodes and adverse drug events.
- Secondary Outcome Measures
Name Time Method Secondary outcomeTimepoint: Additional analyses were done on the correlation of mycophenolic acid area under the concentration-time curve with patient reported outcomes, concomitant tacrolimus dosing, age, sex, MPA formulations.